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test the safety and efficacy of this new formulation in young children

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Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

The challenge

Since 2006, Eswatini has had informal structures in its Ministry of Health dedicated to safeguarding the interests of participants in clinical research. 

With clinical research protocols becoming increasingly complex and often spanning multiple countries, Eswatini has a need to formalise and modernise its ethics review capabilities and ensure consistency with international best practice. In particular, there is a need to equip its national research ethics committee, the National Health Research Review Board (NHRRB), to better fulfill its national oversight role and to build the capacity of institutional research ethics committees so they are better able to assess clinical study protocols and monitor ongoing clinical studies.

The ERECIS project is bringing together a range of international partners from Europe and sub-Saharan Africa to enhance the ethical review capacity of the NHRRB and institutional review boards in Eswatini. It will work with the country’s key bodies involved in clinical research oversight, including the NHRRB, the Eswatini Ministry of Health and its Medicine Regulatory Authority.

The project will ensure that the Eswatini Ministry of Health has an appropriate set of policies and guidelines for clinical research assessment and monitoring, including for ethics review and clinical study monitoring. It will also organise a programme of training to build the capacity of institutional research ethics committees on clinical protocol evaluation and monitoring of clinical trials.

In addition, the project aims to improve the efficiency of ethics review systems, for example by extending use of the RHInnO Ethics electronic platform from the NHRRB to three key institutional review boards. It also aims to improve oversight of ongoing projects through training of institutional review board members on clinical trial assessment and monitoring by clinical quality assurance experts, as well as by facilitating use of the RHInnO Ethics system for clinical study monitoring.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

The ERECIS project will strengthen ethics review capacity in Eswatini, enabling institutional research ethics committees to play a more active role in clinical protocol evaluation and clinical study monitoring and allowing the NHRRB to play a more strategic role. These changes will build national capacity, improve efficiency, and ensure that ethical and regulatory oversight is consistent with the highest international standards.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact